MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00542421

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.

Event Description

It was reported to boston scientific corporation that an exalt model d scope was used during a laparoscopic-assisted endoscopic retrograde cholangiopancreatography (ercp) with duodenal endoscopic mucosal resection (emr) to treat choledocholithiasis and duodenal polyp on (b)(6) 2024.During the procedure, a duodenal mass was identified.Cannulation and stone extraction were performed.The duodenal emr was performed and a snare was used to grasp the resected tissue for removal.While attempting to remove the exalt model d scope from patient's surgically placed port, the endoscopic image was lost.The monitor displayed the scope error screen followed by the loading screen.The staff disconnected and reconnected the scope from the controller and powered the controller off and on.However, visualization could not be regained.The resected specimen was still grasped by the snare inside the exalt scope.An egd scope was used to regain access to the patient's stomach and retrieve the specimen.The procedure was completed.No further information has been obtained despite good faith efforts.

Event Description

It was reported to boston scientific corporation that an exalt model d scope was used during a laparoscopic-assisted endoscopic retrograde cholangiopancreatography (ercp) with duodenal endoscopic mucosal resection (emr) to treat choledocholithiasis and duodenal polyp on (b)(6) 2024.During the procedure, a duodenal mass was identified.Cannulation and stone extraction were performed.The duodenal emr was performed and a snare was used to grasp the resected tissue for removal.While attempting to remove the exalt model d scope from patient's surgically placed port, the endoscopic image was lost.The monitor displayed the scope error screen followed by the loading screen.The staff disconnected and reconnected the scope from the controller and powered the controller off and on.However, visualization could not be regained.The resected specimen was still grasped by the snare inside the exalt scope.An egd scope was used to regain access to the patient's stomach and retrieve the specimen.The procedure was completed.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: the returned device was analyzed, and a visual evaluation noted that the device returned without any visible failure.A functional evaluation noted that an image test was conducted by connecting the umbilicus to a monitor.The monitor showed the image as expected.No other problems with the device were noted.The reported event was not confirmed.During media analysis of photo provided by complainant, it was seen that the monitor shows the sud error message.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) and product label.Based on the findings during the product investigation, the reported event could not be confirmed.There is no reported problem on the exalt model d controller that was used with the scope during the procedure but it is possible that the controller interfered with the correct performance of this device.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18602703
• MDR Text Key: 334733365
• Report Number: 3005099803-2024-00130
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0032753784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female